Improving cognitive function in breast cancer survivors
Pilot Testing of Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer
This study is testing whether a new training program can help breast cancer survivors improve their thinking skills and daily activities after experiencing memory and attention problems related to their cancer treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT06545045 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the feasibility and preliminary effects of metacognitive strategy training (MCST) on improving cognition, activity performance, and quality of life in breast cancer survivors experiencing cancer-related cognitive impairment (CRCI). The study will compare the effects of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach against an inactive control group. Participants will be taught general cognitive strategies that can be applied to various tasks, addressing deficits in executive functioning, memory, and processing speed. The study also seeks to explore the neurophysiological changes associated with the intervention.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors who have completed treatment within the last 6 months to 3 years and report cognitive difficulties.
Not a fit: Patients with active brain-related neurological conditions or other cancer diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance cognitive function and quality of life for breast cancer survivors suffering from cognitive impairments.
How similar studies have performed: While there is no published literature specifically measuring the efficacy of MCST on CRCI in breast cancer survivors, preliminary data suggest potential positive impacts from similar interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * self-reported CRCI (Global Rating of Cognition dysfunction as "Moderately" "Strongly "or "Extremely" AND a Cognitive Failures Questionnaire1 (CFQ) score \>30) * completed treatment for active cancer diagnosis (invasive ductal or lobular BrCA Stages I, II, or III) at least 6 months but not greater than 3 years prior to participation * able to read, write, and speak English fluently * able to provide valid informed consent * have a life expectancy of greater than 6 months at time of enrollment * on stable doses (i.e., no changes in past 90 days) of medications that are known to impact cognitive function (i.e., anti-depressants) Exclusion Criteria: * prior cancer diagnoses of other sites with evidence of active disease within the past year * active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain anatomy or function (e.g., Parkinson's disease, dementia, cerebral infarcts) dementia symptoms as indicated by a score of \<23 on the Montreal Cognitive Assessment (MoCA) * severe depressive symptoms (Personal Health Questionnaire-9 (PHQ-9) score of ≥21) * history of severe traumatic brain injury, prolonged loss of consciousness (e.g., coma) * conditions contraindicated for MRI (e.g., electrical implants, pumps, claustrophobia) * blue-yellow colorblindness * pregnancy The screening methods identified in parentheses next to appropriate inclusion/exclusion criteria will be used to verify appropriate selection of study participants.
Where this trial is running
Columbia, Missouri
- University of Missouri — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Anna E Boone, PhD, OTR/L — University of Missouri Occupational Therapy
- Study coordinator: Anna E. Boone, PhD, OTR/L
- Email: booneae@umsystem.edu
- Phone: 5738827023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.